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ID

26516

Description

Study ID: 100690 Clinical Study ID: NKP100690 Study Title: A randomised, double blind triple dummy, placebo controlled balanced incomplete block crossover study to evaluate the change in response to a 7% CO2 challenge and pharmacokinetics of single oral doses of GW597599 and paroxetine (5 or 7.5 mg) either alone or in combination, or alprazolam (0.75 mg) in healthy volunteers Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 1 Study Recruitment Status: Completed Generic Name: paroxetine Trade Name: Tagonis,Seroxat,Paxil,Paroxat,Deroxat,Aropax Study Indication: Depressive Disorder and Anxiety Disorders CRF Seiten: 255-365

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Versions (1)
  1. 10/18/17 10/18/17 -
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GSK

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October 18, 2017

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Creative Commons BY-NC 3.0
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    7% CO2, GW597599, paroxetine andor alprazolam in healthy volunteers 100690

    English

    Screening Laboratory Collections

    1 forms  
    Administrative Documentation
    Description

    Administrative Documentation

    Alias
    UMLS CUI-1
    C1320722
    Subject Number
    Description

    Subject Number

    Data type

    text

    Alias
    UMLS CUI [1]
    C2348585
    Laboratory Collections for females only, ESTRADIOL and FSH - Ensure a blood sample has been taken for Estradiol and FSH.
    Description

    Laboratory Collections for females only, ESTRADIOL and FSH - Ensure a blood sample has been taken for Estradiol and FSH.

    Alias
    UMLS CUI-1
    C0014912
    UMLS CUI-3
    C0202022
    Exact date and time of blood sampling
    Description

    Date and Time of Blood sampling

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Estradiol
    Description

    Estradiol

    Data type

    text

    Alias
    UMLS CUI [1]
    C0014912
    FSH
    Description

    FSH

    Data type

    text

    Alias
    UMLS CUI [1]
    C0202022
    Clinical Chemistry and Haematology
    Description

    Clinical Chemistry and Haematology

    Alias
    UMLS CUI-1
    C0008000
    UMLS CUI-2
    C0474523
    Exact date and time of blood sampling
    Description

    Date | Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0011008
    UMLS CUI [1,2]
    C0005834
    UMLS CUI [2,1]
    C0040223
    UMLS CUI [2,2]
    C0005834
    Comments
    Description

    Comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Baseline Signs and Symptoms page.
    Description

    Abnormal Value

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205161
    UMLS CUI [1,2]
    C2826633
    Urinanalysis
    Description

    Urinanalysis

    Alias
    UMLS CUI-1
    C0042014
    Exact date and time of urine sampling
    Description

    Date | Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0200354
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Comments
    Description

    Comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Baseline Signs and Symptoms page.
    Description

    Abnormal values

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0205161
    UMLS CUI [1,2]
    C2826633
    Drug Screening (Urine)
    Description

    Drug Screening (Urine)

    Alias
    UMLS CUI-1
    C0202274
    Exact date and time of sampling
    Description

    Date | Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0200354
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Were there any contra-indicated drugs detected? If YES, please record all the relevant contra-indicated drugs below
    Description

    Drug Detection

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1444657
    UMLS CUI [1,2]
    C0013227
    UMLS CUI [1,3]
    C1511790
    Type of Drug
    Description

    Type of Drug

    Data type

    text

    Alias
    UMLS CUI [1]
    C0457591
    Comment
    Description

    Comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    Ensure a 4ml blood sample has been taken to provide serum for screening for HIV antibodies, Hepatitis B surface antigen, Hepatitis C antibody.
    Description

    Ensure a 4ml blood sample has been taken to provide serum for screening for HIV antibodies, Hepatitis B surface antigen, Hepatitis C antibody.

    Alias
    UMLS CUI-1
    C0019682
    UMLS CUI-2
    C0019163
    UMLS CUI-3
    C0019196
    Exact date and time of blood sampling
    Description

    Date | Time

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0005834
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    Comments
    Description

    Comment

    Data type

    text

    Alias
    UMLS CUI [1]
    C0947611
    URINE PREGNANCY TEST (Females only)
    Description

    URINE PREGNANCY TEST (Females only)

    Alias
    UMLS CUI-1
    C0032976
    Was a pregnancy test carried out?
    Description

    Pregnancy Test

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032976
    If 'No', please specify reason
    Description

    Reason No

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C0392360
    UMLS CUI [1,2]
    C0032976
    If 'YES'. please indicate date and time of test and result: Date and Time of pregnancy test:
    Description

    Date | Time Pregnancy Test

    Data type

    datetime

    Alias
    UMLS CUI [1,1]
    C0430060
    UMLS CUI [1,2]
    C0011008
    UMLS CUI [1,3]
    C0040223
    If 'YES'. please indicate date and time of test and result: If 'Positive', withdraw the subject from the study.
    Description

    Result Pregnancy Test

    Data type

    text

    Alias
    UMLS CUI [1]
    C3259477
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    Similar models

    Screening Laboratory Collections

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Administrative Documentation
    C1320722 (UMLS CUI-1)
    Subject Number
    Item
    Subject Number
    text
    C2348585 (UMLS CUI [1])
    Item Group
    Laboratory Collections for females only, ESTRADIOL and FSH - Ensure a blood sample has been taken for Estradiol and FSH.
    C0014912 (UMLS CUI-1)
    C0202022 (UMLS CUI-3)
    Date and Time of Blood sampling
    Item
    Exact date and time of blood sampling
    datetime
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Estradiol
    Item
    Estradiol
    text
    C0014912 (UMLS CUI [1])
    FSH
    Item
    FSH
    text
    C0202022 (UMLS CUI [1])
    Item Group
    C0008000 (UMLS CUI-1)
    C0474523 (UMLS CUI-2)
    Date | Time
    Item
    Exact date and time of blood sampling
    datetime
    C0011008 (UMLS CUI [1,1])
    C0005834 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [2,1])
    C0005834 (UMLS CUI [2,2])
    Comment
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Abnormal Value
    Item
    Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Baseline Signs and Symptoms page.
    boolean
    C0205161 (UMLS CUI [1,1])
    C2826633 (UMLS CUI [1,2])
    Item Group
    C0042014 (UMLS CUI-1)
    Date | Time
    Item
    Exact date and time of urine sampling
    datetime
    C0200354 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Comment
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Abnormal values
    Item
    Are there CLINICALLY SIGNIFICANT ABNORMAL values? If YES, please record diagnosis on Baseline Signs and Symptoms page.
    boolean
    C0205161 (UMLS CUI [1,1])
    C2826633 (UMLS CUI [1,2])
    Item Group
    C0202274 (UMLS CUI-1)
    Date | Time
    Item
    Exact date and time of sampling
    datetime
    C0200354 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Drug Detection
    Item
    Were there any contra-indicated drugs detected? If YES, please record all the relevant contra-indicated drugs below
    boolean
    C1444657 (UMLS CUI [1,1])
    C0013227 (UMLS CUI [1,2])
    C1511790 (UMLS CUI [1,3])
    Type of Drug
    Item
    Type of Drug
    text
    C0457591 (UMLS CUI [1])
    Comment
    Item
    Comment
    text
    C0947611 (UMLS CUI [1])
    Item Group
    Ensure a 4ml blood sample has been taken to provide serum for screening for HIV antibodies, Hepatitis B surface antigen, Hepatitis C antibody.
    C0019682 (UMLS CUI-1)
    C0019163 (UMLS CUI-2)
    C0019196 (UMLS CUI-3)
    Date | Time
    Item
    Exact date and time of blood sampling
    datetime
    C0005834 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Comment
    Item
    Comments
    text
    C0947611 (UMLS CUI [1])
    Item Group
    URINE PREGNANCY TEST (Females only)
    C0032976 (UMLS CUI-1)
    Pregnancy Test
    Item
    Was a pregnancy test carried out?
    boolean
    C0032976 (UMLS CUI [1])
    Reason No
    Item
    If 'No', please specify reason
    text
    C0392360 (UMLS CUI [1,1])
    C0032976 (UMLS CUI [1,2])
    Date | Time Pregnancy Test
    Item
    If 'YES'. please indicate date and time of test and result: Date and Time of pregnancy test:
    datetime
    C0430060 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Item
    If 'YES'. please indicate date and time of test and result: If 'Positive', withdraw the subject from the study.
    text
    C3259477 (UMLS CUI [1])
    Result Pregnancy Test
    Code List
    If 'YES'. please indicate date and time of test and result: If 'Positive', withdraw the subject from the study.
    CL Item
    Positive (Positive)
    CL Item
    Negative (Negative)
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